Centra Health Inc IRB – FDA Warning Letter, Sep 14, 2009

The FDA issued a Warning Letter to Centra Support Building's Institutional Review Board (IRB) following an inspection from September 1-14, 2009. The inspection aimed to assess compliance with 21 CFR Parts 56, 50, 312, and 812, ensuring scientific data validity and human subject protection in device investigations. The inspection revealed serious violations of 21 CFR Part 56. Key deficiencies included: 1) Failure to conduct continuing review of research at least annually (21 CFR 56.109(f)); 2) Failure to ensure IRB reviews proposed research at convened meetings with a majority of members present, specifically regarding conflicted members' abstentions (21 CFR 56.108(c)); 3) Failure to prepare and maintain adequate documentation of IRB activities, including detailed meeting minutes (21 CFR 56.115(a)(2)); and 4) Failure to have adequate written procedures governing IRB functions and operations, particularly for reporting unanticipated problems and determining review frequency (21 CFR 56.108(a)(2) and 56.108(b)(1)(2)). The IRB's September 30, 2009, response was deemed inadequate as it lacked evidence of implemented corrective actions, specific plans, or proposed training. Centra Support Building is required to provide written documentation of all corrective actions taken or planned, along with prevention strategies, within fifteen working days to avoid further regulatory action.